R410--36C24E-22-AP-0064 | 127-22-1-321-0034 | Sensitive Species Independent Review Panel

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E22Q0109 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 541390 with a small business size standard of $16.5M. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW/PWS, Date(s) and place(s) of delivery, and applicable clauses and provisions. Evaluation procedures: Evaluation of offers will be made in accordance with FAR 13.106-2, and award made on the basis of lowest price technically acceptable. BIOMEDICAL LABORATORY RESEARCH AND DEVELOPMENT STATEMENT OF WORK (SOW) 1.0 BACKGROUND The Office of Research Development within the Veterans Administration (VA) was required by law (Public Law 116-94) to develop and submit to Congress a five-year plan to eliminate or reduce research conducted using canines, felines, or non-human primates. The Five-Year Plan that was submitted to Congress on December 31, 2020, called for the formation of two internal committees to implement the plan, a Working Group and and Executive Committee and for the VA to contract with an independent group to monitor plan implementation and provide a final report for the Secretary of VA in the final year of the plan. The ORD Sensitive Species Executive Committee is made up of the Chief Research and Development Officer, the Director of the Biomedical Laboratory R&D Service, the Director of the Rehabilitation R&D Service, the VA Chief Veterinarian and senior VA researchers from the field to guide overall plan development and implementation. The Sensitive Species Working Group made up of Scientific Program Managers from the Biomedical Laboratory and Rehabilitation R&D Services, representative VA investigators from the field and staff from the Office of the Chief Veterinarian to develop plan details, revise as additional information is obtained, and coordinate implementation. 2.0 PURPOSE AND SCOPE The purpose of this contract is to obtain contracted support for independent review of the implementation plan to be developed by the Sensitive Species Working Group. The plan to Congress requires the following: Establish an ORD Sensitive Species Executive Committee and Working Group Establish an education and mentoring program. Establish enhanced review of research involving sensitive animal species including the following: Address, in more detail, the question of why no other species besides canines can be used in the proposed research, in both the application review as well as the local ethics committee review. Better document the animal harm/human benefit assessment and perform a more detailed literature review to verify that canines are needed. Coordinate program with other government agencies. Evaluate approaches to reducing or eliminating the use of canines, felines, and non-human primates in VA research including the following: Partner with veterinary schools to conduct more clinical trials with pets to reduce research canine us Develop mechanisms to allow VA facilities to establish affiliation agreements with the Department of Defense, veterinary schools and other qualified entities to support transitioning research studies to companion animals with spontaneous or accidental Veteran-relevant conditions and benefit the canines participating in the research. Fund studies of the use of tissue culture, organoids, and other related approaches, to replace the use of canines, felines, and NHPs in research. Fund studies of the use of computer simulations and related approaches to replace the use of canines, felines, and NHPs in research. Fund studies to transition research involving canines, felines, and NHPs into human subjects when ethical and feasible. Actively promote new alternate methodologies that meet the unique needs of VA researchers by funding research into human tissues and organs, in vitro techniques such as organ on a chip, and computational approaches. The contractor shall: Have an observer at meetings of the Working Group (WG) and Executive Committee (EC) at least once for each committee per year. Review minutes and meeting notes from every meeting of the EC and WG. Provide a summary of progress of plan implementation to the VA Office of Research and Development Chief Research and Development Officer (CRADO) by December 31 of each of years 2, 3 and 4. Provide a draft of the final report to the Secretary to the CRADO by September 30, 2025, to allow a final report to go to the Secretary by December 31, 2025. The objective of this acquisition is to provide an independent evaluation of the progress on plan implementation, to prepare an annual report for the CRADO and to draft a final report that will go to the Secretary of the VA evaluating the success of the implementation of the Five-Year plan. Approach Phase 1 - Initiation: Objectives The contract will be initiated approximately one year into the plan that was submitted to Congress so the first phase will involve establishing the team members, review of materials provided by ORD related to the plan and meetings between the contractor and members of ORD staff to be briefed on the plan and current status of implementation. Approach Within 30 days of contract awarding, submit a list of candidate reviewers to the CRADO for review and approval to constitute a panel of at least three Subject Matter Experts who will conduct the procedures involved in the oversight. Phase 2 Initial Review: Current Progress Objectives - Provide ongoing oversight of ORD implementation activities and provide annual reports to the CRADO. . Approach Individual reviewers will attend meetings of the EC and WG as observers and will review minutes from the meeting to assess progress against the plan submitted to Congress. By December 31, of each of years 2, 3 and 4 of the plan the reviewers will submit a progress report to the CRADO and will have a face-to-face meeting to present the progress report. Phase 3 - Final Program Review and Reporting Objectives Prepare a final report on the ORD implementation of the five-year plan to Congress for submission to the Secretary of VA by December 31, 2025. Approach The contract panel will draft a report and submit it to the CRADO by September 30, 2025. Deliverables Task 1.0 Contractor to provide an observer at meetings of the Working Group (WG) and Executive Committee (EC) at least once for each committee per year. Review minutes and meeting notes from every meeting of the EC and WG. Provide a summary of progress of plan implementation to the VA Office of Research and Development Chief Research and Development Officer (CRADO) by December 31 of each of years 2, 3 and 4. Task 2.0 Yearly Progress Reports: By December 31 of years 2, 3 and 4 of plan implementation the contractor will submit to the CRADO a progress report detailing progress in implementing the plan submitted to Congress. Final Report: By September 30, 2025 the contractor will submit a draft final report to the CRADO outlining progress in implementing the five-year plan submitted to Congress 3.0 PLACE OF PERFORMANCE The contract services and activities will take place primarily at the VA ORD or at approved Contractor facilities mutually agreed to by the Contractor and the VA, to include the option of teleworking or remote work. 4.0 PERIOD OF PERFORMANCE The period of performance shall be one base period of twelve months and three one-year option periods. 5.0 GENERAL REQUIREMENTS The Contractor will provide a plan, the Project Management Plan (PMP) , as to how tasks will be successfully completed. The PMP shall include a narrative and graphic format displaying schedule, specifically defined milestones, risks, communications, and resource support. The PMP shall explain how the Contractor will coordinate and execute planned, routine, and ad hoc requirements as identified in the PWS. A list of staff assignments supporting each task shall be included once they are determined. The PMP will be submitted within 30 calendar days of contract award. Upon acceptance, the initial PMP will be considered baseline and shall be updated as needed. The Contractor will contact the COR to set up semi-annual evaluation meetings to discuss the status of the contract, deliverables, contract performance. Prior to meeting, the VA COR will coordinate schedules for VA staff to receive input for the evaluation of the performance of the Contractor. The Contractor will prepare agendas and minutes for the semi-annual contract meetings. At the request of the VA COR, the Contractor shall take minutes of conference calls and/or meetings held with the Contractor management, VA COR, and Stakeholders. Copies of these minutes shall be provided to the COR. Hours of Operation: the hours of operation will be specified in the approved Project Management Plan. Travel: Travel is not anticipated under this contract. 6.0 SPECIFIC TASKS AND DELIVERABLES Contractor personnel will provide all administrative and technical support for the tasks outlined below. Task 1: Independent Review and Observation of the Executive Committee and Working Group The Contractor will provide subject matter experts to support the Sensitive Species Executive Committee (EC) and Working Group (WG). Deliverable 1.1 Provide observers at the EC and WG meetings and document attendance. Deliverable 1.2 Review minutes and meeting notes from every meeting of the EC and WG and summarize each meeting in a report to the COR. Deliverable 1.3 Provide a summary of progress of plan implementation to the VA Office of Research and Development Chief Research and Development Officer (CRADO) by December 31 of each of years 2, 3 and 4. DELIVERABLES TABLE TASK DELIVERABLE PLANNED COMPLETION DATE Task 1: Independent Review and Observation of the Executive Committee and Working Group 1.1 Individual reviewers will attend meetings of the EC and WG as observers and will review minutes from the meeting to assess progress against the plan submitted to Congress. As agreed upon in the PMP Task 1: Independent Review and Observation of the Executive Committee and Working Group 1.2 Review minutes and meeting notes from every meeting of the EC and WG and summarize each meeting in a report to the COR. As agreed upon in the PMP Task 1: Independent Review and Observation of the Executive Committee and Working Group 1.3 Provide a summary of progress of plan implementation to the VA Office of Research and Development Chief Research and Development Officer (CRADO) by December 31 of each of years 2, 3 and 4. 12/31 for base and option years 7.0 KEY PERSONNEL a. The Contractor shall propose labor categories they deem essential for successful contractor accomplishment of the work to be performed under this contract and subsequent task orders and option. These individuals are defined as Key Personnel and are those persons whose rsums shall be submitted and marked by the contractor as Key Personnel through submission of the Technical Capability. Substitutions shall only be accepted if in compliance with the Substitution of Key Personnel provision identified below. b. Key Personnel shall include a Sensitive Species Program Manager (SSPM) and two Sensitive Species Subject Matter Experts (SSSME). The SSPM shall be qualified as a SSSME. c. The Program Manager is responsible for direct communication with the VA COR. She/he shall have a minimum of PhD from a recognized institute of higher education; must have 10+ years experience in sensitive species research and oversight and 3 years of management and supervisory experience. d. The SSSMEs will report to the SSPM and shall have a minimum of PhD from a recognized institute of higher education; must have 10+ years experience in sensitive species research e. The Contractor shall demonstrate the appropriate mix and balance of education, academic excellence, training and experience. f. The proposed Key Personnel shall be familiar with the functions of the Sensitive Species protections, Institutional Review Board, HHS, and FDA regulations. g. The Contractor shall identify the specific responsibilities for each key role within the Management Plan. h. The Contractor shall be available for consultation with VA from 8 am to 4:30 pm Eastern Time or as agreed upon with the COR. i. The Contractor shall notify VA in writing within 10 business days of any changes in management plan. All departing key personnel will be replaced within 60 calendar days from the last date of employment. The Contractor shall make every effort to replace departing personnel as quickly as possible. The Contractor will provide written notification of departure, indicating the last date of employment. 7.1 Substitution of Key Personnel. Any personnel the contractor offers as substitutes shall have the ability and qualifications equal to or better than the key personnel who are being replaced. Requests to substitute personnel must be approved by the COR and the CO. All requests for approval of substitutions in personnel shall be submitted to the COR and the CO within 30 calendar days prior to making any change in key personnel. The request shall be written and provide a detailed explanation of the circumstances necessitating the proposed substitution. The contractor shall submit a complete resume for the proposed substitute. The Contractor shall be responsible for managing and overseeing the activities of all Contractor personnel, as well as subcontractor efforts used in performance of this effort, if applicable. The Contractor s management responsibilities shall include all activities necessary to ensure the accomplishment of timely, effective, professional and high-quality support, performed in accordance with the requirements contained herein. 8.0 SECURITY REQUIREMENTS The contractor may need access to VA systems to perform work on this contract. The following security requirements may apply to the contractor: 8.1 POSITION/TASK RISK DESIGNATION LEVEL(S) Position Sensitivity Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, Personnel Suitability and Security Program, Appendix A) Low / Tier 1 Tier 1 / National Agency Check with Written Inquiries (NACI) A Tier 1/NACI is conducted by OPM and covers a 5-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the DOD Defense Central Investigations Index (DCII), Federal Bureau of Investigation (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions. Moderate / Tier 2 Tier 2 / Moderate Background Investigation (MBI) A Tier 2/MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check], a credit report covering a period of 5 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law enforcement check; and a verification of the educational degree. High / Tier 4 Tier 4 / Background Investigation (BI) A Tier 4/BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD Defense Central Investigations Index (DCII), FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, spouse, neighbors, supervisor, co-workers; court records, law enforcement check, and a verification of the educational degree. The position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are: Position Sensitivity and Background Investigation Requirements by Task Task Number Tier1 / Low / NACI Tier 2 / Moderate / MBI Tier 4 / High / BI All Tasks x The Tasks identified above and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the Background Investigation requirements for Contractor individuals, based upon the tasks the particular Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required Background Investigation Level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal. The C&A requirements do not apply and a Security Accreditation Package is not required. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS Contractor Responsibilities: The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate Background Investigation. The Contractor shall bear the expense of obtaining background investigations. Within 3 business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations. The roster shall contain the Contractor s Full Name, Full Social Security Number, Date of Birth, Place of Birth, and individual background investigation level requirement. The preferred method to send the Contractor Staff Roster or Social Security Number is by encrypted e-mail. If unable to send encrypted e-mail, other methods which comply with FIPS 140-2 are to encrypt the file, use a secure fax, or use a traceable mail service. The Contractor should coordinate the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized. The following forms are required to be completed: Optional Form 306; Self-Certification of Continuous Service; VA Form 0710; and Completed Security and Investigations Center (SIC) Fingerprint Request Form. The Contractor personnel will receive an email notification from the Security and Investigation Center (SIC), through the Electronics Questionnaire for Investigations Processes (e-QIP) identifying the website link that includes detailed instructions regarding completion of the investigation documents (NACI-SF85). The Contractor personnel shall submit all required information related to their background investigations utilizing the Office of Personnel Management s (OPM) Electronic Questionnaire for Investigations Processing (e-QIP). The Contractor shall complete the e-QIP questionnaire and digitally sign e-QIP within 7 days of receipt of initiation email. The Contractor shall print the signature pages, and send them to the COR for electronic submission to the SIC. These should be submitted to the COR within 7 days of receipt of the e-QIP notification email. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. In the event that damages arise from work performed by Contractor provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC) or Closed, No Issues (SAC) finger print results, training delineated in VA Handbook 6500.6 (Appendix C, Section 9), and, the signed Contractor Rules of Behavior. However, the Contractor will be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of the Office of Personnel Management (OPM). The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract. Failure to comply with the Contractor personnel security investigative requirements may result in termination of the contract for default. 8.2 GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 8.3 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 8.4. VA INFORMATION CUSTODIAL LANGUAGE Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 8.5. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 8.6. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breac...